Regional Manager, Quality Management

What Quality Management contributes to Cardinal HealthQuality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Quality Management provides strategic oversight, leadership and direction within the Quality function.Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.Responsibilities Provides overall direction and management of the QA function that supports their assigned PET manufacturing sites in the United StatesIs responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues according to procedure, compliant investigation, execution of validation protocols and site related records managementProvides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols / reports, investigations, procedures and change controlsProviding general oversight to ensure the identity, strength, quality and purity of the drug product released at their sitesEnsuring that all raw materials and finished product meet specificationsEnsuring the review of production records and release of finished product at their assigned sitesEnsuring that all procedures are followed and that all errors and failures to meet specification are appropriately investigated and corrected at their sitesEnsuring regional quality coverage at all assigned sitesInteracts with regulatory agencies, as necessary and ensures the closure any regional FDA commitments on time and its related documentation/objective evidence appropriateEnsure that the procedures are properly followed and adequate for their intended useImplements and monitors quality performance measures for the site and reports them to the Director, Quality in a timely mannerInteracts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and proceduresAssess data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP’s and regulatory requirementsCollaborates with their assigned Area Manager and others to build strategic alliances within the PET network; negotiates to build broad-based support and/or persuades others in order to meet deadlinesIdentifies opportunities to improve efficiency while providing flawless transactions, services and products; manages monetary assets and other resources to optimize cost effectivenessEnsures that customers have a positive experience; commits to meet or exceed customer expectationsThe Regional Quality Manager (RQM) has the authority to:Approves change control documents (up to a moderate change)Initiates investigations and provide direction for corrective actionDetermines, develops and delivers trainingDevelops, reviews and revises quality proceduresMakes hiring decisions for their direct reportsApproves personnel related issues (PTO, travel, etc.)Deploys employee goals, objectives and performance evaluationsCarries out other duties as described in policies and procedures or as assigned by the Director/QualityQualificationsBachelor’s degree in related field, or equivalent work experience, preferred8-12 years of experience, preferred2-5 years of experience in the Pharmaceutical Industry preferred1-3 years of experience in a quality management role preferredThorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirementsKnowledgeable to validation practices and principlesExcellent interpersonal, organizational and communication skillsDemonstrated leadership and the ability to motivate and influence othersProficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practicesAbility to travel to all assigned sites (50%-75%)Must be located near PET facility or relocation may be requiredWhat is expected of you and others at this levelManages department operations and supervises professional employees, front line supervisors and/or business support staffParticipates in the development of policies and procedures to achieve specific goalsEnsures employees operate within guidelinesDecisions have a short term impact on work processes, outcomes and customersInteracts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior managementInteractions normally involve resolution of issues related to operations and/or projectsGains consensus from various parties involvedScheduleOnsite role at a PET manufacturing facilityCandidate must be flexible to work different shifts or schedules based on business needWork hours may be subject to change50% - 75% travelWork EnvironmentThe primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.Anticipated salary range:$105,100 - $150,100Bonus eligible:YesBenefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close:08/24/2026 *if interested in opportunity, please submit application as soon as possible.The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.#LI-TF1Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.To read and review this privacy notice click hereSummaryLocation: NJ-East Rutherford PET; CT-East Hartford PET; MD-Beltsville PET; PA-Sharon Hill Phil PETType: Full time